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- FDA approves cemiplimab-rwlc for adjuvant treatment of . . .
On October 8, 2025, the Food and Drug Administration approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals Inc ) for the adjuvant treatment of adults with cutaneous squamous cell carcinoma
- LIBTAYO® (cemiplimab-rwlc) | Official HCP Website
LIBTAYO® (cemiplimab-rwlc) is a prescription medicine indicated for the treatment of adult patients with advanced NSCLC, CSCC, BCC, and as an adjuvant treatment for high-risk CSCC See Important Safety full Prescribing Information
- Libtayo (cemiplimab-rwlc) FDA Approval History - Drugs. com
Libtayo FDA Approval History Last updated by Judith Stewart, BPharm on Oct 9, 2025 FDA Approved: Yes (First approved September 28, 2018) Brand name: Libtayo Generic name: cemiplimab-rwlc Dosage form: Injection Company: Sanofi Treatment for: Squamous Cell Carcinoma, Basal Cell Carcinoma, Non Small Cell Lung Cancer Libtayo (cemiplimab-rwlc) is a programmed death receptor-1 (PD-1) blocking
- FDA Approves Libtayo for Adjuvant Treatment of High-Risk CSCC
Findings showed cemiplimab reduced the risk of disease recurrence or death by 68% compared with placebo The Food and Drug Administration (FDA) has approved Libtayo ® (cemiplimab-rwlc) for the
- Libtayo® (cemiplimab-rwlc) Approved in the U. S. as First and . . .
The FDA evaluated Libtayo under Priority Review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in the treatment of serious conditions
- Cemiplimab Gains FDA Approval for Adjuvant High-Risk CSCC
The FDA has approved adjuvant cemiplimab (Libtayo) for adults with high-risk cutaneous squamous-cell carcinoma after surgery and radiation
- Libtayo (cemiplimab-rwlc) - OHSU
Used as continuation maintenance therapy in patients who have achieved a tumor response or stable disease after first-line therapy with cemiplimab, pemetrexed, and either carboplatin or cisplatin for non-squamous cell histology; OR
- FDA approves cemiplimab-rwlc for metastatic or locally . . .
Listen to the FDA D I S C O podcast about this approval On Sept 28, 2018, the Food and Drug Administration approved cemiplimab-rwlc (LIBTAYO, Regeneron Pharmaceuticals Inc ) for patients with
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